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New treatment option for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Official title Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT05819853
What this study is testing
What is Semaglutide Injectable Product (Wegovy and/or Ozempic)?
Semaglutide Injectable Product (Wegovy and/or Ozempic) is an investigational medicine, being studied as a potential treatment for pcos (polycystic ovary syndrome) of bilateral ovaries.
Also referred to as Semaglutide (Wegovy and/or Ozempic).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 35, women only
You may be able to join if
- Female
- Ages 12-35 years
- Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
- Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines
- Initial BMI based on age and weight:
You likely can't join if
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history...
- Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of...
- Weight loss medications in the last 6 months
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
- Severe illness requiring hospitalization within 60 days.
- Diabetes, defined as Hemoglobin A1C ≥6.5%
See the full eligibility criteria
- Female
- Ages 12-35 years
- Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
- Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines
- Initial BMI based on age and weight:
- If \<18 years, initial BMI percentile ≥95
- If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia
- Must be weight stable within ±5kg in the 3 months prior to enrollment
- Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia
- Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g., copper IUD) for the entire study period. For participants who receive...
- For participants in the metformin + semaglutide group, participants must have been stable on ≥ 1500 mg of metformin a day for at least 3 months by time of screening
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by...
- Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10...
- Weight loss medications in the last 6 months
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
- Severe illness requiring hospitalization within 60 days.
- Diabetes, defined as Hemoglobin A1C ≥6.5%
- Anemia, defined as Hemoglobin \< 12 mg/dL
- Diagnosed major psychiatric or developmental disorder limiting informed consent. 10) Known liver disease other than NAFLD, or AST or ALT \>125 IU/L. 11) Personal history of pancreatitis 12) Known renal disease of any...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 12 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.